Blog
RSS FeedPosted by Michael Wonder on 30 Mar 2018
Sunovion submits new drug application to the FDA for apomorphine sublingual film (APL-130277) for the treatment of off episodes associated with Parkinson's disease
30 March 2018 - Submission is supported by Phase 3 clinical study data showing that the investigational medicine demonstrated superior efficacy ...
Posted by Michael Wonder on 30 Mar 2018
Statement from FDA Commissioner on FDA’s efforts to enhance the patient perspective and experience in drug development and review
30 March 2018 - Benefit-risk assessment is at the heart of what we do to ensure that Americans have access ...
Posted by Michael Wonder on 30 Mar 2018
Insmed submits new drug application to FDA for ALIS in NTM lung disease caused by MAC
29 March 2018 - ALIS previously designated as an orphan drug, breakthrough therapy and qualified infectious disease product. ...
Posted by Michael Wonder on 29 Mar 2018
FDA expands approval of Blincyto for treatment of a type of leukaemia in patients who have a certain risk factor for relapse
29 March 2018 - The U.S. FDA granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor ...
Posted by Michael Wonder on 28 Mar 2018
To make copycat drugs more competitive, the FDA is taking a harder look at the originals
28 March 2018 - The FDA wants to improve branded drugs to help bolster the biosimilars market. ...
Posted by Michael Wonder on 28 Mar 2018
FDA approves Toujeo Max SoloStar
27 March 2018 - Max SoloStar holds more insulin than any other long-acting insulin pen. ...
Posted by Michael Wonder on 27 Mar 2018
FDA authorises first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices
27 March 2018 - The U.S. FDA today permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for ...
Posted by Michael Wonder on 27 Mar 2018
Lexicon Pharmaceuticals announces regulatory submissions for sotagliflozin to treat adults with type 1 diabetes
26 March 2018 - New drug application submitted to U.S. FDA and marketing authorisation application submitted to EMA. ...
Posted by Michael Wonder on 27 Mar 2018
Palatin Technologies announces submission of bremelanotide NDA to FDA for treatment of hypoactive sexual desire disorder in premenopausal women
26 March 2018 - Palatin Technologies announced today that its exclusive North American licensee for bremelanotide, AMAG Pharmaceuticals, has submitted a ...
Posted by Michael Wonder on 27 Mar 2018
Bayer announces completion of rolling submission of new drug application in the U.S. for larotrectinib for the treatment of TRK fusion cancer
26 March 2018 - Bayer today announced that its collaboration partner Loxo Oncology has completed the rolling submission of a new ...
Posted by Michael Wonder on 26 Mar 2018
Seattle Genetics and Astellas receive FDA breakthrough therapy designation for enfortumab vedotin in locally advanced or metastatic urothelial cancer
26 March 2018 - Seattle Genetics and Astellas Pharma today announced that the U.S. FDA has granted breakthrough therapy designation ...
Posted by Michael Wonder on 23 Mar 2018
Progenics Pharmaceuticals announces three month extension of PDUFA date for Azedra (iobenguane I 131)
22 March 2018 - Progenics Pharmaceuticals announced today that the Company has received notification from the U.S. FDA that the ...
Posted by Michael Wonder on 22 Mar 2018
House approves ‘right-to-try’ bill giving seriously ill patients access to experimental drugs
22 March 2018 - The House approved “right-to-try” legislation on Wednesday that would bypass drug regulators and give critically ill ...
Posted by Michael Wonder on 22 Mar 2018
FDA wants to help unproductive drug makers
22 March 2018 - America’s pharmaceutical giants may also need to rethink their business model. ...
Posted by Michael Wonder on 22 Mar 2018
Novartis drug Tasigna approved by FDA to treat children with rare form of leukaemia
22 March 2018 - New indication approved under FDA Priority Review designation; provides clinicians with paediatric-specific safety and clinical data. ...